Regulatory Diagnostics Manager/ Regulatory Diagnostics Associate Director

Summary The Regulatory Diagnostics Manager (RDM) / Regulatory Diagnostics Associate Director (RDAD) for Precision Diagnostics is responsible for the implementation of strategic plans for the development of diagnostics, including Companion Diagnostics (CDx), pertaining to Novartis' innovative medicines portfolio and marketed products. The RDM/ RDAD works with senior members of the Regulatory Affairs Precision Diagnostics Team and partners with Digital, Data and Clinical Innovation (DDCI) and partner companies to ensure regulatory compliance and the effective delivery of precision diagnostics. Key Responsibilities Regulatory Strategy and Implementation Supports the diagnostics regulatory strategy for precision IVDs and CDx (e.g. US, EU, Japan, China). Responsible for submissions in the pre‑market and post‑market space including IDE, SD, PSA and pre‑market authorization submissions. Ensures regulatory input for early development and late‑stage programs is incorporated into the overall drug development strategy. Partners with RA country organizations to align on local regulatory requirements and deliver timely submissions. Facilitates preparation, filing and finalization of briefing books and coordinates pre‑submission or other meetings with HAs related to precision diagnostics and CDx development. Develops, manages and implements plans for timely response to HA requests and coordinates follow‑up activities. Member of RA sub‑team and Biomarker Development Sub‑team (BDST) as appropriate. Training and Compliance Supports compliance activities for Novartis clinical trials related to global regulations on precision diagnostics and CDx. Ensures regulatory compliance of partner companies for CDx development and IVD deliverables, and supports roll‑out of new procedures, SOPs and working practices related to IVD and CDx development. Performance Indicators Successful implementation of regulatory diagnostics strategies with timely submissions for precision IVDs and CDx. Full compliance with IVD and LDT rules for our clinical trials. Identification of precision IVD and CDx needs for Novartis programs. Strong partnership with RA diagnostics team members and the RA community. Adherence to Novartis policies and guidelines. Essential Requirements Manager Science based BS or MS with requisite experience; advanced degree (MS, PhD, PharmD) considered a plus. Minimum 2–4 years of experience in the pharmaceutical industry with relevant diagnostics, IVD or CDx development. Demonstrated experience contributing to IVD/CDx regulatory projects and/or submissions. Understanding of IDE, MAA, NDA/BLA, 510(k), PMA submissions. Understanding of assay validation and CLIA. Understanding of clinical trials. Strong interpersonal, communication and negotiation skills. Associate Director Science based BS or MS with requisite experience; advanced degree (MS, PhD, PharmD) considered a plus. Minimum 4–6 years of experience in the pharmaceutical industry with relevant diagnostics, IVD or CDx development. Demonstrated experience contributing to IVD/CDx regulatory projects. Understanding of IDE, MAA, NDA/BLA, 510(k), PMA submissions. Understanding of assay validation and CLIA. Understanding of clinical trials. Strong interpersonal, communication and negotiation skills. Compensation The salary for this position ranges between $114,100 and $211,900 (Manager) and $145,600 and $270,400 (Associate Director) per year. Salaries are determined based on skills and experience and may be reviewed annually. The compensation includes a performance‑based cash incentive and, at the appropriate level, eligibility for annual equity awards. Benefits US‑based eligible employees receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. Employees also receive a generous time‑off package including vacation, personal days, holidays and other leaves. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please contact [email protected] or call +1‑877‑395‑2339 and include the job requisition number in your message. #J-18808-Ljbffr